Hiring for Senior Drug Safety Physician (senior Medical Reviewer) - Drug Safety in Mysore, for Exp. 1 - 5 yrs at Bioclinca India Pvt Ltd..

  • Esteemed client of Orion TrueTech Services India
  • Mysore, Karnataka, India
  • Nov 07, 2017
Full time Pharma, Healthcare & Biotechnology Jobs

Job Description

Job Description:JOB TITLE: Senior Drug Safety Physician (Senior Medical Reviewer) LOCATION: Mysore, India YEARS OF EXPERIENCE: 2-5 years experience in PV EDUCATION: MBBS/MD (in any discipline) ESSENTIAL DUTIES AND RESPONSIBILITIES:&amp amp nbsp As a Medical Reviewer Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion Determine seriousness and relatedness across products as assigned Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative. Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas Escalate complex case issues on client product(s) to the medical review team of the client as appropriate Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate Acquire and maintain knowledge of applicable Global Health Authority regulations Perform any other drug safety related activities as assigned Participate in internal and external audits and inspections by clients and health authorities SPECIALIZED KNOWLEDGE AND SKILLS: Experience with relevant safety databases and related software applications Proven experience in customer handling and relationship. Proven ability to perform task management. Must have good presentation skills and the ability to give presentations.&amp amp nbsp Knowledge of the Life Sciences Industry and life cycle of drug. Relevant product and industry knowledge.